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Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules.
Vaccine. 2007 Jan 02; 25(1):102-8.V

Abstract

BACKGROUND

Early immunization to protect infants against hepatitis A (HA) is recommended in intermediate or high endemic areas of the world, but little is known of the effects of maternal antibodies on the immune response. We studied the immunogenicity and reactogenicity of an inactivated HA vaccine administered in two different schedules to 2-month-old infants in an intermediate/high endemic area in Argentina.

METHODS

In this double-blind, randomized study 131 infants received either three doses (at 2, 4, 6 months of age [Group A]) or one dose (at 6 months of age [Group B]) of the pediatric inactivated HA vaccine, Avaxim 80, and a booster dose at 15-18 months. HAV antibodies were measured (ELISA) at 2, 7, 15-18 and 16-19 months of age. Immediate (30 min after injection) and solicited local and systemic reactions were recorded for 7 days after each injection.

RESULTS

Of 107/131 subjects (81.6%) who completed the study and who provided final serum samples after booster dose, 94 (87.8%) were seropositive at enrolment (>20 mIU/mL) with geometric mean concentrations (GMC) of 2989 and 3637 mIU/mL in Groups A and B, respectively. One month post-booster GMCs were 8236 mIU/ml (95% CI; 6304, 10760) and 1687 mIU/ml (1148, 2479) in Groups A and B, respectively, with 100% seroprotection.

CONCLUSIONS

The HA vaccine was well tolerated and induced immunological priming in both groups during the first year of life in spite of the presence of maternal antibodies. Post-booster GMCs achieved after one or three primary doses suggest a long-term protection against HA.

Authors+Show Affiliations

Hospital de Niños Ricardo Gutiérrez, Guido 2676, Piso 10, 1425 Buenos Aires, Argentina. eduardoluislopez@fibertel.com.arNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16914234

Citation

López, E L., et al. "Hepatitis a Vaccination of Argentinean Infants: Comparison of Two Vaccination Schedules." Vaccine, vol. 25, no. 1, 2007, pp. 102-8.
López EL, Contrini MM, Xifró MC, et al. Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules. Vaccine. 2007;25(1):102-8.
López, E. L., Contrini, M. M., Xifró, M. C., Cattaneo, M. A., Zambrano, B., Dumas, R., Rouyrre, N., & Weber, F. (2007). Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules. Vaccine, 25(1), 102-8.
López EL, et al. Hepatitis a Vaccination of Argentinean Infants: Comparison of Two Vaccination Schedules. Vaccine. 2007 Jan 2;25(1):102-8. PubMed PMID: 16914234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hepatitis A vaccination of Argentinean infants: comparison of two vaccination schedules. AU - López,E L, AU - Contrini,M M, AU - Xifró,M C, AU - Cattaneo,M A, AU - Zambrano,B, AU - Dumas,R, AU - Rouyrre,N, AU - Weber,F, Y1 - 2006/07/28/ PY - 2005/05/09/received PY - 2006/03/07/revised PY - 2006/07/07/accepted PY - 2006/8/18/pubmed PY - 2007/3/3/medline PY - 2006/8/18/entrez SP - 102 EP - 8 JF - Vaccine JO - Vaccine VL - 25 IS - 1 N2 - BACKGROUND: Early immunization to protect infants against hepatitis A (HA) is recommended in intermediate or high endemic areas of the world, but little is known of the effects of maternal antibodies on the immune response. We studied the immunogenicity and reactogenicity of an inactivated HA vaccine administered in two different schedules to 2-month-old infants in an intermediate/high endemic area in Argentina. METHODS: In this double-blind, randomized study 131 infants received either three doses (at 2, 4, 6 months of age [Group A]) or one dose (at 6 months of age [Group B]) of the pediatric inactivated HA vaccine, Avaxim 80, and a booster dose at 15-18 months. HAV antibodies were measured (ELISA) at 2, 7, 15-18 and 16-19 months of age. Immediate (30 min after injection) and solicited local and systemic reactions were recorded for 7 days after each injection. RESULTS: Of 107/131 subjects (81.6%) who completed the study and who provided final serum samples after booster dose, 94 (87.8%) were seropositive at enrolment (>20 mIU/mL) with geometric mean concentrations (GMC) of 2989 and 3637 mIU/mL in Groups A and B, respectively. One month post-booster GMCs were 8236 mIU/ml (95% CI; 6304, 10760) and 1687 mIU/ml (1148, 2479) in Groups A and B, respectively, with 100% seroprotection. CONCLUSIONS: The HA vaccine was well tolerated and induced immunological priming in both groups during the first year of life in spite of the presence of maternal antibodies. Post-booster GMCs achieved after one or three primary doses suggest a long-term protection against HA. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/16914234/Hepatitis_A_vaccination_of_Argentinean_infants:_comparison_of_two_vaccination_schedules_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(06)00830-9 DB - PRIME DP - Unbound Medicine ER -